Shire submits EU MAA on ulcerative colitis drug

UK drugmaker Shire has submitted a Marketing Authorization Application to European regulators for SPD476, an investigational compound being studied for the induction and maintenance of clinical and endoscopic remission in active mild-to-moderate ulcerative colitis.

If approved, SPD476 would offer a once-daily mesalazine treatment for the condition and, according to the the firm, the mesalazine market segment for UC, in which SPD476 will compete, is worth around $1.6 billion a year. Shire's chief executive, Matthew Emmens, noted that "currently there is no once-daily oral treatment for ulcerative colitis so we look forward to offering patients the efficacy and convenience of SPD476."

Shire submitted a New Drug Application for the agent to the US Food and Drug Administration in December 2005 and has also recently filed a New Drug Submission for it with Health Canada.